Study of COVID-19 Infection and Its Clinical Prognosis in Chronic Hepatitis B Patients With Antiviral Therapy

NCT05792878 | Unknown

• 1 other identifier: DTXY26
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This is a two-way (retrospective and prospective) study of COVID-19 infection in an observational cohort of patients with chronic hepatitis B treated with antiviral therapy. Patients with chronic hepatitis B who received anti-HBV treatment in the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled. After enrollment, demographic data of patients, information on antiviral treatment of chronic hepatitis B, COVID-19 vaccination, COVID-19 infection and COVID-19 incidence and treatment from January 2022 to pre enrollment, and data on HBV virus and serology, clinical biochemistry, liver and lung imaging, COVID-19 nucleic acid and COVID-19 antibody examination of patients were collected. After enrollment, prospective anti-HBV treatment, HBV virology, clinical biochemistry, liver imaging and COVID-19 infection and morbidity were observed. The patients with COVID-19 infection during the prospective observation period were observed for COVID-19 infection, onset and treatment, including body temperature, clinical symptoms, signs, cardiac examination, pulmonary imaging, COVID-19, clinical biochemistry, disease severity, time of virus negative conversion, hospital stay and outcome. The influence of COVID-19 infection on liver disease and the influence of interferon anti-HBV treatment on COVID-19 infection, its pathogenesis and prognosis were studied.

Conditions

Chronic Hepatitis B; COVID-19 Infection

Keywords

chronic hepatitis; COVID-19 infection; interferon

Outcome Measures

Primary Outcomes (1)

• The rate of COVID-19 infection.

  The rate of chronic hepatitis B patients infected with COVID-19 after initial antiviral treatment.

  48 weeks after therapy

Secondary Outcomes (2)

• The rate of severe disease after COVID-19 infection.

  48 weeks after therapy

• The hospitalization rate and duration of COVID-19.

  48 weeks after therapy

Study Arms (2)

Interferon treatment group

Patients with chronic hepatitis B who received antiviral treatment with Interferon at the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled.

Drug: Interferon

nucleoside analogues treatment group

Patients with chronic hepatitis B who received antiviral treatment with nucleoside analogues at the Second Department of Hepatology, Beijing Ditan Hospital Affiliated to Capital Medical University from February 2022 to December 2023 were enrolled

Drug: nucleoside analogues

Interventions

Interferon DRUG

The naive treated patients with chronic hepatitis B were given antiviral treatment with interferon according to their condition.

Also known as: peg-interferon alpha

Interferon treatment group

nucleoside analogues DRUG

The naive treated patients with chronic hepatitis B were given antiviral treatment with nucleoside analogues according to their condition.

Also known as: NAs

nucleoside analogues treatment group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

During 48 weeks of the prospective observation period, the treated patients continuously use the original treatment. After the initial treatment patients are enrolled, they receive antiviral treatment with interferon or nucleoside analogues according to the needs of the disease. During the treatment period, the corresponding virology, serology, clinical biochemistry and liver imaging examinations of hepatitis B antiviral treatment were carried out every 3-6 months. During COVID-19 infection, the patient shall be checked for clinical symptoms, clinical biochemistry, blood routine, pulmonary imaging, COVID-19 and antibodies, as well as other organs and functional indicators required by clinical needs.

You may qualify if:

• \) HBsAg positive for 6 months.
• \) Patients undergoing initial or ongoing antiviral treatment.
• \) HBeAg status and HBV DNA level are not limited.

You may not qualify if:

• \) Patients with decompensated liver cirrhosis or previous decompensated liver cirrhosis.
• \) At the same time, it is associated with other viral infections, such as hepatitis A virus, hepatitis C virus, hepatitis D virus, hepatitis E virus, HIV, etc. - 3) Accompanied with other serious physical and mental diseases, including uncontrolled primary kidney, heart, lung, vascular, nervous, digestive, severe metabolic diseases (such as uncontrolled hyperthyroidism, diabetes, serious complications, adrenal diseases, etc.), immunodeficiency disease, and accompanied with serious infection; History of active or suspected malignant tumors or malignant tumors.

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Department of Hepatology Division 2, Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; COVID-19; Hepatitis, Chronic

Interventions

Interferons; nas

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Yao Xie, Doctor

  Beijing Ditan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Xie, Doctor

CONTACT

8610-84322200; xieyao00120184@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Hepatology Division 2, Beijing Ditan Hospital, Capital Medical University

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: March 31, 2023
• Study Start: September 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Locations

CN (1)